Phase I Study of Induction Therapy With VELCADE and Vorinostat in Patients With Surgically Resectable Non-Small Cell Lung Cancer

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT00731952
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Velcade and Vorinostat — DRUG
    Subjects will receive one of 3 doses of Velcade (at a dose of 1.0 - 1.6 mg/m2 once weekly for 3 weeks) and one of 4 doses of Vorinostat (at a dose of 100mg every day 3 times a week for 3 weeks to 300mg twice per day, 3 times per week for 3 weeks). Doses determined by a predetermined escalation schedule.

Study Details

The purpose of this study is to find out what effects (both good and bad) two medications (VELCADE and Vorinostat) have on patients who have certain types of lung cancer. The study is "dose escalating" meaning that patients will receive different doses of medication depending on when they enter the study. Participation in the study will last approximately 3 months and will include an initial screening visit, a visit once each week for 3 weeks to receive the study medications, and then 2 additional visits around the time of your surgery to remove your lung cancer tumor.

Key Dates

Start date
Jun 30, 2006
Status verified
May 2017
Primary completion
Dec 31, 2012
Completion
Mar 31, 2014

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Velcade and Vorinostat
    Subjects will receive one of 3 doses of Velcade (at a dose of 1.0 - 1.6 mg/m2 once weekly for 3 weeks) and one of 4 doses of Vorinostat (at a dose of 100mg every day 3 times a week for 3 weeks to 300mg twice per day, 3 times per week for 3 weeks). Doses determined by a predetermined escalation schedule.

Primary Outcome Measure

Adverse events [ Time Frame: 30 days post surgical resection ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in Charlottesville, VA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Virginia· Charlottesville, VA

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